Biota Pharmaceuticals Inc. focuses on the discovery and development of direct-acting antivirals to treat infections that affect various patients worldwide. The company has four product candidates in clinical development that address viral infections that have limited therapeutic options. vapendavir, an oral treatment for human rhinovirus (HRV) infections in moderate-to-severe asthmatics, being evaluated in the company’s ongoing Phase 2b SPIRITUS trial; BTA074, a Phase 2 topical antiviral treatment for genital warts caused by human papillomavirus (HPV) types 6 & 11; BTA585, an oral fusion (F) protein inhibitor in Phase 1 development for the treatment of RSV-A and RSV-B infections; and laninamivir octanoate, a one-time, inhaled treatment in Phase 2 development for influenza A and B infections. The company also has preclinical RSV non-fusion inhibitor program that complements its F-protein inhibitor BTA585. Vapendavir (BTA798) The company is developing vapendavir (BTA798), a potent antiviral capsid binder that is designed to bind to a highly conserved pocket in the HRV capsid and interfere with receptor binding and/or related early steps in the infectious cycle. Vapendavir is a potent inhibitor of picornaviruses and has been shown to inhibit the replication of a range of HRV serotypes and the replication of a majority of new HRV clinical isolates in tissue culture assays. The median EC50 value for vapendavir against the 100 HRV serotypes is 5.8 ng/mL (15.2 nM). Vapendavir has also demonstrated antiviral activity against other clinically relevant enteroviruses (EV), including EV- 71 and poliovirus types 1, 2, and 3. In 2014, the company completed enrollment in a Phase 1 study entitled ‘A Randomized, Single-Center, Open-Label, Two-Period, Two-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Product Formulations in Healthy Volunteers’ designed to establish the systemic exposure profile of a single dose of a vapendavir free-base tablet formulation compared to the exposure profile following a single dose of two vapendavir phosphate salt capsules, which was the formulation used in prior clinical trials. In 2014, the company also completed a drug-drug interaction study entitled ‘A Phase 1, Randomized, Open-Label Study to Evaluate the Effect of Vapendavir (BTA798) on the Pharmacokinetics of Orally Administered Midazolam, a CYP3A4 Substrate, in Healthy Male and Female Volunteers’. BTA074 (AP611074) BTA074 is in development for the treatment of genital warts, as well as the orphan indication of RRP. BTA074 is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, E1 and E2, an interaction that is an essential step for HPV DNA replication and thus, viral production and pathogenesis. BTA074 is a first-in-class directing acting antiviral specific to HPV and possesses new mechanism of action that could be exploited to treat infections caused by HPV types 6 & 11. BTA074 was selected for clinical development among approximately 1200 compounds tested. BTA074 is developed by combining chemo-informatics modeling and in cellulo screening of E1/E2 protein-protein interactions. These studies showed that BTA074 inhibits the HPV6 and HPV11 E1/E2 interaction or HPV DNA replication in cellulo with an IC50 of 0.5-1 ‘M. Moreover, BTA074 is selective for low-risk types HPV 6 and HPV 11, since it does not inhibit replication of HPV 18 or E1/E2 protein interactions of other HPVs. The company plans to initiate a Phase 2 trial in late 2015 to further validate BTA074 favorable local skin tolerability profile and antiviral activity. In 2013, a Phase 2a clinical trial of BTA074 5% gel was completed. BTA585 The company’s major compound, BTA585, is a potent, non-cytotoxic and selective inhibitor of the RSV F protein. In August 2015, the company commenced dosing in a 50-subject, randomized, placebo-controlled, Phase 1 single ascending dose clinical trial to evaluate the safety and PK of BTA585 in healthy volunteers. In addition to BTA585, the company identified a series of potent RSV non-fusion inhibitors that the company int
biota pharmaceuticals inc
2500 Northwinds Parkway
Alpharetta, GA 30009
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